Efficacy of 0.05% Cyclosporine A Eye Drops Combined With Absorbable Tear Duct Plugs in the Treatment of Dry Eye in Sjögren's Syndrom

NCT07171710 | Enrolling By Invitation

• 1 other identifier: zhangyi2024-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effectiveness of 0.05% cyclosporine A eye drops in combination with smart plug absorbable lacrimal duct plugs in the monotherapy of cyclosporine for SSDE.

Conditions

Dry Eye Disease

Keywords

dry eye disease; Absorbable Tear Duct Plugs; Cyclosporine

Outcome Measures

Primary Outcomes (5)

• The Ocular Surface Disease Index (OSDI) score

  The Ocular Surface Disease Index (OSDI) is a tool used for screening and diagnosing patients with dry eye syndrome. It assesses the severity of dry eye, covering three dimensions: ocular symptoms, visual function and environmental triggers

  Assessed after 3 months of the trial

• VAS score

  A swimming ruler of about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that was unbearable.

  Assessed after 3 months of the trial

• BUT

  Tear film break-up time,It is a tear stability test

  Assessed after 6 months of the trial

• tear river height

  The concave arc formed at the junction of tears and eyelid margin was observed under a slit lamp microscope, and the tear secretion was indirectly evaluated by measuring the tear retention height

  Assessed after 6 months of the trial

• IVCM examination

  It can observe the physiological and pathological changes of ocular surface tissues and cell structures in vivo, and has wide applications in the diagnosis and treatment evaluation of infectious keratitis, ocular surface assessment of dry eye disease, evaluation of the therapeutic effect of ocular surface surgery, and early screening of diabetes.

  Assessed after 6 months of the trial

Study Arms (2)

Experimental group

OTHER

One eye was randomized to recieve a Smart plug absorbable lacrimal duct plugs, and cyclosporin A 0.05% cyclosporine A eye drops were administered three times daily to both eyes.

Drug: 0.05% Cyclosporine Eye Drops

Control group

OTHER

cyclosporin A 0.05% cyclosporine A eye drops were administered three times daily to both eyes.

Drug: 0.05% Cyclosporine Eye Drops; Device: Smart plug absorbable lacrimal duct plugs

Interventions

0.05% Cyclosporine Eye Drops DRUG

Cyclosporin A 0.05% eye drops were administered twice daily to both eyes

Control group; Experimental group

Smart plug absorbable lacrimal duct plugs DEVICE

The lacrimal duct embolization implant is performed by partially sealing the tear discharge duct to increase the lubrication of natural tears on the eye surface.

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients aged ≥18 years who had a confirmed diagnosis of Sjögren's syndrome (SS).
• Dry eye diagnosis required both subjective and objective criteria: participants presented with one or more ocular surface symptoms such as dryness, foreign body sensation, burning, fatigue, discomfort, redness, or fluctuating vision, with an Ocular Surface Disease Index (OSDI) score of ≥13; Noninvasive Tear Break-Up Time (NIBUT)≤10s and Schirmer I test≤ 5 mm/5 min
• voluntarily participate in this study and sign written informed consent

You may not qualify if:

• Any patient with structural abnormalities (eyelid scars, entropion, trichiasis, etc.);
• Patients with any inflammation or active structural changes in the iris or anterior chamber;
• Glaucoma;
• Patients who have undergone previous ophthalmic surgery or have undergone timely closure;
• Patients using any topical medications other than artificial tears, 0.1% flumirone eye drops, and 0.05% cyclosporine A eye drops;
• Patients who received any systemic or topical antibacterial or anti-inflammatory drug treatment 90 days before the start of the study;
• Patients wearing contact lenses;
• Patients with corneal infection;
• Corneal diseases (marginal ulcers, opacity, scars, bullous keratopathy, conjunctival laxity, eyelid ball adhesions or tumors);
• Pregnancy;
• Study the changes of immunosuppressive system treatment in the first 90 days.

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (1)

• Dong Y, Cao JF, Li ZC, Yang XY, Chen L. Enhanced efficacy of 0.05% cyclosporine a combined with absorbable punctal plugs in Sjogren's syndrome-associated dry eye: a paired-eye clinical trial. Front Med (Lausanne). 2026 Jan 6;12:1674647. doi: 10.3389/fmed.2025.1674647. eCollection 2025.

  PMID: 41567664 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Yi Zhang

  Tianjin Eye Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 12, 2025
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2024-10

Locations

CN (1)